Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137527
Status:
TERMINATED
Last Update Posted:
2014-01-17
First Post:
2005-08-26
Brief Title:
Brain Oxygenation Monitoring in Patients Undergoing Coronary Artery Bypass Surgery
Sponsor:
Atlantic Health System
Organization:
Atlantic Health System
Study Overview
Official Title:
Prospective Randomized Trial of Cerebral Oximetry Monitoring in Patients Undergoing Coronary Artery Bypass Surgery
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether intraoperative brain oxygenation monitoring in cardiac surgery patients is effective in reducing postoperative neurologic and neurocognitive dysfunction
Detailed Description:
This study represents a prospective randomized assessment of the potential clinical and economic benefit to be derived from the continuous non-invasive monitoring of regional cerebral oxygen saturation rSO2 during cardiac surgery employing cardiopulmonary bypass CPB Previous studies have shown that low rSO2 values obtained during surgery are highly associated with postoperative frontal lobe dysfunction cognitive declines disorientation and other clinical indices of prolonged recovery Low rSO2 values are thought to reflect the development of tissue hypoxia within susceptible regions of the cerebral cortex during the non-pulsatile perfusion of CPB Rapid detection and correction of such episodes should help avoid regional hypoxia and its attendant postoperative sequelae This study will assess neurologic psychometric and quality of life markers of brain dysfunction which could result from CPB Each study patient will be assessed both pre- and postoperatively pre-hospital discharge and at three months for neurologic and neurocognitive dysfunction
Comparisons Intervention versus control group Patients assigned to the intervention rSO2-monitored group will be managed with conservative measures designed to maintain the rSO2 value at or above its preoperative value Such measures include increases in pump flow blood pressure anesthetic dose arterial oxygen tension carbon dioxide tension and hematocrit Those patients in the control group will be managed according to current established practice Although rSO2 is also recorded in this group the monitors readings are blinded
Comparisons Intervention versus control group Patients assigned to the intervention rSO2-monitored group will be managed with conservative measures designed to maintain the rSO2 value at or above its preoperative value Such measures include increases in pump flow blood pressure anesthetic dose arterial oxygen tension carbon dioxide tension and hematocrit Those patients in the control group will be managed according to current established practice Although rSO2 is also recorded in this group the monitors readings are blinded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None